AsthmaINCANCT01529697
Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
A study testing Active Feedback in people with Asthma, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Active Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months
- At least one exacerbation in the previous year with systemic glucocorticoids
- Uncontrolled/Partially Controlled Asthma by GINA guidelines
Who cannot join
- Allergy to salmeterol/fluticasone
- Patients Controlled by GINA guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration
The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.
In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.
- Conditions
- Asthma
- Being tested
- Active Feedback
- Keywords
- Asthma, Inhaler use
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active FeedbackBehavioural
Also called Feedback from a computer log of inhaler use
The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.
| Study group | Role | What they receive |
|---|---|---|
| Active Feedback | Active comparator | In this arm patients will receive monthly review and education on inhaler technique and use based on a computer download of their last month of inhaler use Receives: Behavioral: Active Feedback |
| Control | Placebo comparator | In this arm patients will be reviewed monthly, however will not have information from INCA device to tailor inhaler education. Receives: Behavioral: Active Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate
The rate of actual adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed. The actual inhaler adherence, expressed as cumulative drug exposure, is calculated by combining the time of use along with the interval between doses (correct time is twice a day, in a period not less than 6 hours between the last dose and the subsequent dose or at a time greater than 18 hours apart from the previous dose.) and incorporating, by audio analysis, if the inhaler was used correctly.
Measured: at three months
Secondary outcomes (5)
Asthma quality of life score
The asthma quality of life score will be related to adherence, The baseline asthma quality of life score and the quality of life score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
Measured: at 3 months
Peak Expiratory Flow Rate
The peak expiratory flow rate will be related to adherence, The baseline peak expiratory flow rate and the peak expiratory flow rate at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
Measured: at 3 months
Asthma Control Test
The asthma control test score will be related to adherence, The baseline asthma control test score and the score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
Measured: at 3 months
Asthma Exacerbations
The frequency in exacerbations over the three months will be compared between the active and control arms.
Measured: over 3 months
Asthma Reliever Medication Use
The change in frequency of reliever use per month from baseline to the end of the study will be compared between active and control patients.
Measured: over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard Costello, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529697
- Sponsor's protocol ID
- BeaumontH
- Acronym
- INCA
- Status last verified
- Jan 2016
- First submitted
- 7 Feb 2012
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
PubMed 35691614Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW. A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma. Eur Respir J. 2018 Jan 4;51(1):1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.
PubMed 29301919Sulaiman I, Seheult J, MacHale E, Boland F, O'Dwyer SM, Rapcan V, D'Arcy S, Cushen B, Mokoka M, Killane I, Ryder SA, Reilly RB, Costello RW. A Method to Calculate Adherence to Inhaled Therapy that Reflects the Changes in Clinical Features of Asthma. Ann Am Thorac Soc. 2016 Nov;13(11):1894-1903. doi: 10.1513/AnnalsATS.201603-222OC.
PubMed 27467125Sulaiman I, Mac Hale E, Holmes M, Hughes C, D'Arcy S, Taylor T, Rapcan V, Doyle F, Breathnach A, Seheult J, Murphy D, Hunt E, Lane SJ, Sahadevan A, Crispino G, Diette G, Killane I, Reilly RB, Costello RW. A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma. BMJ Open. 2016 Jan 4;6(1):e009350. doi: 10.1136/bmjopen-2015-009350.
PubMed 26729384
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
- ClinicalTrials.gov ID
- NCT01529697
- Acronym / sponsor ID
- INCA / BeaumontH
- Conditions
- Asthma
- Keywords
- Asthma, Inhaler use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration
The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.
In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Feedback | Active comparator | Behavioral: Active FeedbackIn this arm patients will receive monthly review and education on inhaler technique and use based on a computer download of their last month of inhaler use |
| Control | Placebo comparator | Behavioral: Active FeedbackIn this arm patients will be reviewed monthly, however will not have information from INCA device to tailor inhaler education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months
- At least one exacerbation in the previous year with systemic glucocorticoids
- Uncontrolled/Partially Controlled Asthma by GINA guidelines
Key exclusion criteria (2 listed)
- Allergy to salmeterol/fluticasone
- Patients Controlled by GINA guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active FeedbackAlso: Feedback from a computer log of inhaler useThe inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient. | Behavioural | Active Feedback, Control |
Primary outcome
Adherence rate
Time frame: at three months
The rate of actual adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed. The actual inhaler adherence, expressed as cumulative drug exposure, is calculated by combining the time of use along with the interval between doses (correct time is twice a day, in a period not less than 6 hours between the last dose and the subsequent dose or at a time greater than 18 hours apart from the previous dose.) and incorporating, by audio analysis, if the inhaler was used correctly.
5 secondary outcomes
Asthma quality of life score
Time frame: at 3 months
Peak Expiratory Flow Rate
Time frame: at 3 months
Asthma Control Test
Time frame: at 3 months
Asthma Exacerbations
Time frame: over 3 months
Asthma Reliever Medication Use
Time frame: over 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Derived from this study: PubMed 35691614Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
- Derived from this study: PubMed 29301919Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW. A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma. Eur Respir J. 2018 Jan 4;51(1):1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.
- Derived from this study: PubMed 27467125Sulaiman I, Seheult J, MacHale E, Boland F, O'Dwyer SM, Rapcan V, D'Arcy S, Cushen B, Mokoka M, Killane I, Ryder SA, Reilly RB, Costello RW. A Method to Calculate Adherence to Inhaled Therapy that Reflects the Changes in Clinical Features of Asthma. Ann Am Thorac Soc. 2016 Nov;13(11):1894-1903. doi: 10.1513/AnnalsATS.201603-222OC.
- Derived from this study: PubMed 26729384Sulaiman I, Mac Hale E, Holmes M, Hughes C, D'Arcy S, Taylor T, Rapcan V, Doyle F, Breathnach A, Seheult J, Murphy D, Hunt E, Lane SJ, Sahadevan A, Crispino G, Diette G, Killane I, Reilly RB, Costello RW. A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma. BMJ Open. 2016 Jan 4;6(1):e009350. doi: 10.1136/bmjopen-2015-009350.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Costello, MD principal investigator
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Feedback in people with Asthma, run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate (time frame: at three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01529697, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.